Employment Clinical Data Specialist

Company Overview

Auxogyn, Inc. is a privately held company that is revolutionizing the field of reproductive medicine by translating scientific discoveries in early embryo development into effective clinical tools. The Company's flagship product, the Eeva™ Test, is designed to improve embryo selection by providing clinicians with objective information to more confidently select embryo(s) for transfer to help achieve better IVF outcomes. Eeva's proprietary software automatically analyses embryo development against scientifically and clinically validated cell-division parameters discovered by researchers at Stanford University, shown to be predictive of the embryo's developmental potential.

Eeva received CE mark in July 2012 and is currently available for use in the European Union. The Eeva Test is pending FDA clearance and is limited to investigational use only in the United States.

Auxogyn is privately held and funded by Kleiner Perkins Caufield & Byers, Merck Serono Ventures, SR One and TPG Biotech.

Position Summary

As a member of Auxogyn Clinical Research Team, this position is responsible for management of data and assuring quality of data delivery. This position is the key liaison with internal and external business partners responsible for the development of data management systems and data cleaning activities. This position will have a moderate amount of interaction with clinical study leadership, data management support teams, and statisticians.

Additional responsibilities include definition of data management related business requirements ensuring quality of data, and supporting and/or working with project teams, disciplines or functions. Provides ongoing support and subject matter expertise for data management related activities

Major Duties and Responsibilities

  • Initiate, plan, execute and manage all aspects of data management from case report form development to the final database lock. This includes case report form design and development, database/edit check specification requirements definition, user acceptance testing, creation and maintenance of the data management plan and the data quality plan
  • Ensure the successful execution of data management elements of the project plan. This includes monitoring tasks and managing timelines related to data management deliverables, database development and database lock/freeze/snapshot
  • Plan, execute and manage multiple projects of moderate complexity, utilizing project management tool and techniques
  • Maintain and provide project timelines and effectively communicate project status
  • Provide communication of risk & mitigation actions for all data management related deliverables
  • Define data review requirements and processes to ensure delivery of the highest quality of data (study unique needs, end point analysis, higher level review, escalation of issues)
  • Follow and implement data management standards, best practices and assure Standard Operating Procedures compliance
  • Communicate with company leadership regarding the status of specific projects
  • Facilitate small group discussions on moderately complex data management topics

Preferred Qualifications

Education and/or Job Experience

  • Data management experience in medical device and/or pharmaceutical industry
  • Experience analyzing clinical protocol requirements and translating them into data management requirements
  • Experience with case report form design
  • Experience working in clinical data management applications (e.g. Oracle Clinical, Clindex) and report tools
  • Experience working with technology partners (database developers, testers)
  • Experience working with EDC
  • Project Management experience
  • Experience with project management tools, spreadsheets, word processing, database applications (e.g. Microsoft Project, Excel, MS Word)
  • Experience writing SOP’s and DMP’s
  • Bachelor’s degree
  • 5+ years clinical research experience

Special Skills, Abilities, and Requirements

  • Expert knowledge of good data management and good documentation practices
  • Strong knowledge of FDA 21 CFR Part 11 Regulation
  • In-depth knowledge of Health Insurance Portability and Accountability Act

Demonstrated Personal Characteristics

Candidate must be driven to deliver results with the ability to establish rapport, earn trust, and effectively collaborate with others. Essential attributes of the successful candidate is one who:

  • Is Action Oriented:
    • Motivated by results
    • Full of energy when faced with challenges
    • Able to make and implement tough decisions
    • “Proactive” as opposed to “reactive”
  • Deals with Ambiguity:
    • Can be flexible and adaptable in a complex, changing environment
    • Can comfortably handle risk and uncertainty
  • Works Collaboratively:
    • Practices attentive and active listening
    • Has the patience to hear people out and to search for constructive input
  • Exemplifies Interpersonal Savvy and Integrity:
    • Relates well to all kinds of people—both inside and outside the company
    • Builds constructive and effective relationships
    • Uses diplomacy and tact
    • Adheres to an appropriate set of core values and beliefs
    • Always acts with uncompromising integrity

We offer a competitive compensation package including health insurance, stock options and a challenging work environment. We are an equal opportunity employer.

Qualified candidates please send your resume to [email protected].

Back to Employment